MAUDE Adverse Event Report: SPR THERAPEUTICS SPRINT; PERIPHERAL NERVE STIMULATOR

Model Number	9600-9288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Bacteremia (4846)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented in the emergency room for an infection.The patient's lead was removed and antibiotics were administered.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint reports that the patient's lead was removed prior to the planned end of treatment date due to an infection.The patient presented at the emergency room (er) for assessment of the issue and was administered intravenous (iv) antibiotics for treatment of the issue.The patient was reportedly prescribed oral antibiotics for further treatment of the issue.Blood tests performed at the er to test for infection confirmed the presence of bacteria in the patient's blood (i.E., bacteremia); additional information regarding the type of bacteria identified was not available at the time of investigation.No additional information regarding resolution of the reported issue was available at the time of investigation.If additional information becomes available regarding resolution of the issue, this investigation will be updated.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; suite 500; cleveland, OH 44122
• MDR Report Key: 19098494
• Report Number: 3011035812-2024-00002
• Device Sequence Number: 20759518
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)250202(10)72367432
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2025
• Device Model Number: 9600-9288
• Device Lot Number: 72367432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male